This is used to check if an ingredient has been listed by FDA and to get its code. This link points to the excel spreadsheet. This spreadsheet contains column Preferred Substance Name, Substance Name and UNII Code. e.g. Distilled Water is the Substance Name but Water is the Preferred Substance Name.
counter_ion_validation.xml : This file contains the list of ions which can’t be a part of active moiety of the product. e.g. if we have active ingredient as Sodium Chloride then Chloride is a counter ion and can’t be present in the active moiety. So the correct active moiety in this case is Sodium Cation.
otcval.xml: This is a list of citations which are to be used when the marketing category is either OTC Monograph/ OTC Monograph final.
postal_codes_val.xml: This is a list of countries. If an Establishment is located in any of these countries and the postal code is not specified for them then it is valid. Besides that postal code is required for all the sites/establishments.
solid_oral_dosage_validation.xml: When a dosage form belongs to this list, the characteristics of Color, Shape, Scoring and Size are required.
medguide.xml: This is a list of applications that are required to include a Medication Guide.
otcval_final.xml / otc_monograph final.xls: This is a list of final monograph citations matched with active ingredients
otcval_not_final.xml / otc_monograph not final.xls: This is a list of not-final monograph citations matched with active ingredients
Controlled Vocabulary (aka picklists, SPL terminology)
- Location of vocabulary xml files: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm169455.htm
- Business Operations: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162527.htm (business_operation.xml)
- This is used in the Establishment Registration Form/ Labeler and Manufacturing Information to specify the operation types of the Establishment(s).
- Document Type: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162063.htm (document_type.xml)
- This is used to assign the correct code and displayname to the label created.
- Section Headings: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162057.htm (section_heading.xml)
- This is used to assign correct codes and displaynames for the sections created in the document.
- [New - 29-Mar-2010] Pointers to Drug Nomenclature Monographs:
Drug Listing Data- SPL Color: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162043.htm (color.xml)
- This is used to specify the color(s) for the product/drug. This is a required field when the dosage form is a solid.
- Dosage Forms: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162038.htm (dosage_form.xml)
- This is used to select the appropriate dosage form.
- Flavor: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162541.htm (flavor.xml)
- This is used to specify flavor(s) of the drug.
- Marketing Category: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162528.htm (marketing_category.xml)
- This is used to select the Marketing Category of the drug.
- Package Type: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm163380.htm (package_type.xml)
- This is used to select the package type of the drug.
- Route of Administration: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162034.htm (route_of_administration.xml)
- Specifies the possible route of administration
- SPL Shape: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162047.htm (shape.xml)
- This is used to select the shape of the drug. This is a required field when the dosage form is a solid.
- UNII (Unique Ingrédient Identifier): http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162523.htm (unii.xml)
- This is used to check if an ingredient has been listed by FDA and to get its code. This link points to the excel spreadsheet. This spreadsheet contains column Preferred Substance Name, Substance Name and UNII Code. e.g. Distilled Water is the Substance Name but Water is the Preferred Substance Name.
- To check current statuses of inactive ingredient refer to http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm.
- Units of Presentation/ Units of Measure: http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm162049.htm / http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm168397.htm (unit_of_presentation.xml)
- This is used for strength of Ingredient, Package and Part Quantity.
The following files are the files used for validating http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm169455.htm and sub link Additional Validation Files.